Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

DACLIZUMAB - INJECTION

(dack-LIZ-you-mab)

COMMON BRAND NAME(S): Zenapax

Uses

This medication is used to prevent organ rejection in patients receiving kidney transplants. This drug is used in combination with other drugs (e.g., cyclosporine and steroids).

OTHER

Uses

This drug may also be used for other types of organ transplants.

How To Use

This medication is given by injection into a vein (IV) after proper dilution in a saline solution. The dose is given over a 15 minute period, every 14 days for a total of 5 doses, beginning no more than 24 hours before transplantation. Review all the preparation and administration instructions in the product package and ask your doctor or pharmacist if any information is unclear. Do not use if solution is cloudy or colored. Do not shake the vial. This medication should be given by a health care professional.

Side Effects

Nausea, vomiting, constipation or diarrhea may occur. If these effects persist or worsen, notify your doctor. Report promptly: stomach pain, headache, dizziness, chest pain, arm or leg swelling, trouble breathing, coughing, sore throat, fever, poor wound healing, bleeding, muscle pain, increased thirst or hunger, cloudiness or unusual change in amount of urine. Unlikely but report promptly: bloody urine or stools, weakness, leg cramps, increased sweating, mood/mental changes, arthritis pain, pain at the site of injection. In the unlikely event you have an allergic reaction to this drug, seek medical attention immediately. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. In a heart transplant study, use of daclizumab in combination with cyclosporine, mycophenolate mofetil, and corticosteroids may have infrequently caused serious reactions (sometimes death). Consult your doctor or pharmacist for more details. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Before using this drug, tell your doctor your medical history, including: allergies (especially drug allergies), heart or lung disease, diabetes, high blood pressure, cancer, serious infection. Limit alcohol intake as it may enhance certain side effects of this medication. Since this drug may cause dizziness, use extreme caution if operating machinery or performing hazardous tasks (e.g., driving). It is recommended that women of childbearing age should use effective birth control before, during, and for 4 months following the use of this product. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug is excreted into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding. Caution is advised when this drug is used in the elderly.

Drug Interactions

Tell your doctor of all nonprescription and prescription medication you may use, especially of: steroids (e.g., prednisone), other immunosuppressive drugs (e.g., cyclosporine, mycophenolate, azathioprine). Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately.

Notes

Do not share this medication with others. Monitoring, including laboratory tests, is performed during use of this drug.

Missed Dose

If you miss a dose, consult your doctor or pharmacist to establish a new dosing schedule promptly.

Storage

Vials should be refrigerated between 36 and 46 degrees F (2-8 degrees C) away from light. Do not shake or freeze. Diluted medication is stable for 24 hours at 39 degrees F (4 degrees C), or for 4 hours at room temperature. Discard any unused portion of the vial.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).